BIVONA TRACHEOSTOMY TUBES

Tube Tracheostomy And Tube Cuff

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Bivona Tracheostomy Tubes.

Pre-market Notification Details

• Device ID: K083641
• 510k Number: K083641
• Device Name: BIVONA TRACHEOSTOMY TUBES
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. Gary, IN 46406
• Contact: Daniel Coates
• Correspondent: Daniel Coates; SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. Gary, IN 46406
• Product Code: JOH
• CFR Regulation Number: 868.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-09
• Decision Date: 2009-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15021312006407	K083641	000
15021312005806	K083641	000
15021312005783	K083641	000
15021312005776	K083641	000
15021312005769	K083641	000
15021312005752	K083641	000
15021312005745	K083641	000
15021312005738	K083641	000
15021312005721	K083641	000
15021312005714	K083641	000
15021312005707	K083641	000
15021312005691	K083641	000
15021312005813	K083641	000
15021312005820	K083641	000
15021312006391	K083641	000
15021312005929	K083641	000
15021312005912	K083641	000
15021312005905	K083641	000
15021312005899	K083641	000
15021312005882	K083641	000
15021312005875	K083641	000
15021312005868	K083641	000
15021312005851	K083641	000
15021312005844	K083641	000
15021312005837	K083641	000
15021312005684	K083641	000
15021312005585	K083641	000
15021312005578	K083641	000
15021312000382	K083641	000
15021312000375	K083641	000
15021312000368	K083641	000
15021312000344	K083641	000
15021312000269	K083641	000
15021312000252	K083641	000
15021312000245	K083641	000
15021312000238	K083641	000
15021312000184	K083641	000
15021312000139	K083641	000
15021312000122	K083641	000
15021312000399	K083641	000
15021312000405	K083641	000
15021312005561	K083641	000
15021312005554	K083641	000
15021312005547	K083641	000
15021312000757	K083641	000
15021312000740	K083641	000
15021312000733	K083641	000
15021312000726	K083641	000
15021312000719	K083641	000
15021312000696	K083641	000
15021312000665	K083641	000
15021312000436	K083641	000
15021312000115	K083641	000
15021312516838	K083641	000
15021312516692	K083641	000
15021312516685	K083641	000
15021312516678	K083641	000
15021312014754	K083641	000
15021312014747	K083641	000
15021312014730	K083641	000
15021312014723	K083641	000
15021312014716	K083641	000
15021312007046	K083641	000
15021312007039	K083641	000
15021312007022	K083641	000
15021312516708	K083641	000
15021312516715	K083641	000
15021312516821	K083641	000
15021312516814	K083641	000
15021312516807	K083641	000
15021312516791	K083641	000
15021312516784	K083641	000
15021312516777	K083641	000
15021312516760	K083641	000
15021312516753	K083641	000
15021312516746	K083641	000
15021312516739	K083641	000
15021312516722	K083641	000
15021312007015	K083641	000
15021312007008	K083641	000
15021312006995	K083641	000
15021312006773	K083641	000
15021312006766	K083641	000
15021312006506	K083641	000
15021312006490	K083641	000
15021312006483	K083641	000
15021312006476	K083641	000
15021312006469	K083641	000
15021312006452	K083641	000
15021312006445	K083641	000
15021312006438	K083641	000
15021312006421	K083641	000
15021312006780	K083641	000
15021312006797	K083641	000
15021312006988	K083641	000
15021312006971	K083641	000
15021312006964	K083641	000
15021312006957	K083641	000
15021312006926	K083641	000
15021312006919	K083641	000
15021312006902	K083641	000
15021312006896	K083641	000
15021312006889	K083641	000
15021312006810	K083641	000
15021312006803	K083641	000
15021312006414	K083641	000